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Adcirca (Tadalafil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Adcirca (Tadalafil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (309)
Death (84)
Life Threatening Events (12)
Disability (6)

Reports by Reaction Type

Death (55)Dyspnoea (36)Headache (22)Pneumonia (22)Hospitalisation (19)Vision Blurred (14)Fluid Retention (13)Pain (11)Off Label Use (11)Fatigue (11)Back Pain (11)Hypotension (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Adcirca (Tadalafil). For a complete list or a specific selection of reports, please use the links above.

Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Hypoacusis, Visual Impairment, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Spiriva; Hydralazine HCL; Lisinopril; Klor-CON; Lasix



Possible Adcirca side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Combivent; Nexium; Jantoven; Januvia; Glimepiride; Prednisone TAB; Pravachol; Lasix; Amlodipine Besylate; Lisinopril; Amlodipine; Coreg



Possible Adcirca side effects in male

Reported by a physician from Canada on 2012-08-23

Patient: male, weighing 126.0 kg (277.2 pounds)

Reactions: Overdose, Renal Failure, Skin Ulcer, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2009-01-01

Adcirca
    Dosage: 20 mg, tid
    Administration route: Oral

Other drugs received by patient: Pantoprazole Sodium; Metformin; Aldactone; Diltiazem; Bosentan; Lasix; Potassium Chloride; Warfarin Sodium



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Death, Hospitalisation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Adcirca
    Dosage: 40 mg, qd
    Indication: Pulmonary Hypertension

Adcirca
    Dosage: 20 mg, qd
    Start date: 2012-02-27



Possible Adcirca side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Carbon Dioxide Increased, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a physician from Netherlands on 2012-08-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male

Reactions: Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a physician from Canada on 2012-08-16

Patient: female

Reactions: Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-15

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male

Reactions: Pneumonia Bacterial, Lung Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in

Reported by a physician from Canada on 2012-08-13

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male

Reactions: Death, Pulmonary Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 113.4 kg (249.4 pounds)

Reactions: Off Label Use, Thrombosis in Device

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Prednisone TAB; Lisinopril; Protonix; Coreg; Ascorbic Acid; Cyanocobalamin; Nephrocaps; Vitamin D; Aspirin; Celexa



Possible Adcirca side effects in

Reported by a physician from Canada on 2012-08-08

Patient:

Reactions: Condition Aggravated

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-08-07

Patient: male, weighing 112.0 kg (246.4 pounds)

Reactions: Hepatic Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Actos; Torsemide; LAC-B; Slow-K; Spironolactone; Ambrisentan; Beraprost Sodium; Ambrisentan; Urso 250; Neutrogin



Possible Adcirca side effects in 52 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 52 year old male

Reactions: Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Lasix; Allopurinol; Uralyt / 01779901 /; Tracleer; Famotidine; Ferrous Citrate; Aspirin; Sotalol Hydrochloride



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-08-06

Patient: male

Reactions: Off Label Use, Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tracleer



Possible Adcirca side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Death, Hospitalisation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in 74 year old female

Reported by a physician from United States on 2012-08-03

Patient: 74 year old female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a physician from United States on 2012-08-03

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in female

Reported by a physician from Japan on 2012-08-03

Patient: female

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-24

Ambrisentan
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2010-12-14
    End date: 2011-01-08

Ambrisentan
    Dosage: 7.5 unk, unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-01-09

Flolan
    Dosage: 30 ng/kg/min
    Start date: 2011-02-05
    End date: 2011-02-10

Flolan
    Dosage: 10 ng/kg/min
    Start date: 2010-12-30
    End date: 2011-01-20

Flolan
    Dosage: 0.6 ng/kg/min
    Start date: 2010-12-11
    End date: 2010-12-12

Flolan
    Dosage: 7 ng/kg/min
    Start date: 2010-12-20
    End date: 2010-12-30

Flolan
    Dosage: 5 ng/kg/min
    Start date: 2010-12-16
    End date: 2010-12-20

Flolan
    Dosage: 3 ng/kg/min
    Start date: 2010-12-12
    End date: 2010-12-16

Flolan
    Dosage: 32 ng/kg/min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-02-10

Flolan
    Dosage: 28 ng/kg/min
    Start date: 2011-02-04
    End date: 2011-02-05

Flolan
    Dosage: 20 ng/kg/min
    Start date: 2011-01-20
    End date: 2011-02-04

Other drugs received by patient: Mucodyne; Entomol; Gaster / 00706001 /; Heparin; Depas; Entomol; Alendronate Sodium; Depas; Medicon / 00048102 /; Sulfamethoxazole and Trimethoprim; Gaster / 00706001 /; Warfarin Sodium



Possible Adcirca side effects in male

Reported by a physician from Canada on 2012-08-02

Patient: male, weighing 76.0 kg (167.2 pounds)

Reactions: Pulmonary Hypertension, Right Ventricular Failure, Intermittent Claudication, Aortic Aneurysm, Anaemia, Hypothyroidism, Hypertension, Epistaxis

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca
    Dosage: 40 mg, bid
    Start date: 2010-08-20

Adcirca
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-05-31

Other drugs received by patient: Ferrous Gluconate; Juice Plus; Spironolactone; Senokot; Lasix; Ferrous Fumarate; Coumadin; Lorazepam; Metoprolol Tartrate; Atrovent; Crestor; Docusate; Digoxin



Possible Adcirca side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca



Possible Adcirca side effects in male

Reported by a physician from United States on 2012-07-31

Patient: male

Reactions: Dyspnoea, Visual Impairment, Dizziness, Headache, Hypoaesthesia, Paraesthesia

Drug(s) suspected as cause:
Adcirca
    Dosage: 20 mg, qd
    Indication: Pulmonary Hypertension
    Start date: 2012-07-23

Adcirca
    Dosage: 10 mg, qd
    End date: 2012-07-25



Possible Adcirca side effects in female

Reported by a physician from Japan on 2012-07-31

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-24

Flolan
    Start date: 2011-02-04
    End date: 2011-02-05

Flolan
    Start date: 2010-12-16
    End date: 2010-12-20

Flolan
    Start date: 2011-01-20
    End date: 2011-02-04

Flolan
    Start date: 2011-02-10

Flolan
    Start date: 2010-12-30
    End date: 2011-01-20

Flolan
    Start date: 2010-12-12
    End date: 2010-12-16

Flolan
    Start date: 2011-02-05
    End date: 2011-02-10

Flolan
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-11
    End date: 2010-12-12

Flolan
    Start date: 2010-12-20
    End date: 2010-12-30

Volibris
    Dosage: 7.5mg per day
    Administration route: Oral
    Start date: 2011-01-09

Volibris
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-14
    End date: 2011-01-08

Other drugs received by patient: Famotidine; Medicon; Mucodyne; Entomol; Sulfamethoxazole and Trimethoprim; Warfarin Sodium; Alendronate Sodium; Famotidine; Heparin; Depas



Possible Adcirca side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male

Reactions: Pulmonary Haemorrhage, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tyvaso



Possible Adcirca side effects in male

Reported by a physician from Japan on 2012-07-30

Patient: male

Reactions: Off Label Use, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Adcirca

Other drugs received by patient: Tracleer



Possible Adcirca side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female

Reactions: Pain

Drug(s) suspected as cause:
Adcirca

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